METHOD FOR IMPLANTING A CARDIOVASCULAR VALVE

• US 20080177381A1
• Filed: 01/17/2008
• Published: 07/24/2008
• Est. Priority Date: 01/19/2007
• Status: Active Grant

• Current Assignee: Cleveland Clinic Foundation
• Original Assignee: Cleveland Clinic Foundation
• Inventors: Navia, Jose Luis, Chen, Ji-Feng
• Granted Patent: US 8,105,375 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/0095 Packages or dispensers for prostheses or other implants for intraocular lenses A61F2/1691; for dental surgery A61C19/02
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2/9524 Iris-type crimpers
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2250/0092 Means for cleaning prostheses
• CPC Class Codes: A61L 27/3625 Vascular tissue, e.g. heart valves
• CPC Class Codes: A61L 27/3629 Intestinal tissue, e.g. small intestinal submucosa
• CPC Class Codes: A61L 27/3687 characterised by the use of chemical agents in the treatment, e.g. specific enzymes, detergents, capping agents, crosslinkers, anticalcification agents
• CPC Class Codes: A61L 27/3691 characterised by physical conditions of the treatment, e.g. applying a compressive force to the composition, pressure cycles, ultrasonic/sonication or microwave treatment, lyophilisation
• CPC Class Codes: Y10T 29/49925 Inward deformation of aperture or hollow body wall

Abstract

A method is provided for implanting a valve having at least one valve leaflet within the cardiovascular system of a subject. One step of the method includes preparing a substantially dehydrated bioprosthetic valve and then providing an expandable support member having oppositely disposed first and second ends and a main body portion extending between the ends. Next, the substantially dehydrated bioprosthetic valve is attached to the expandable support member so that the substantially dehydrated bioprosthetic valve is operably secured within the main body portion of the expandable support member. The expandable support member is then crimped into a compressed configuration and placed at a desired location within the cardiovascular system of the subject. Either before or after placement at the desired location, fluid or blood re-hydrates the substantially dehydrated bioprosthetic valve.

Claims

1. A method for implanting a valve having at least one valve leaflet within the cardiovascular system of a subject, said method comprising the steps of:

preparing a substantially dehydrated bioprosthetic valve;

providing an expandable support member having oppositely disposed first and second ends and a main body portion extending between the ends;

attaching the substantially dehydrated bioprosthetic valve to the expandable support member so that the substantially dehydrated bioprosthetic valve is operably secured within the main body portion of the expandable support member;

crimping the expandable support member into a compressed configuration; and

placing the expandable support member at a desired location within the cardiovascular system of the subject.

2. The method of claim 1, wherein said step of placing the expandable support member at a desired location within the cardiovascular system of the subject further comprises the steps of:

loading the expandable support member into a delivery catheter;

obtaining access to the desired location;

delivering the expandable support member to the desired location; and

expanding the expandable support member into engagement with the cardiovascular tissue at the desired location.

3. The method of claim 1, wherein said step of preparing a substantially dehydrated bioprosthetic valve further comprises the steps of:

obtaining a bioprosthetic valve;

treating the bioprosthetic valve with an aqueous treatment solution comprising a dimensional stabilizer for a time sufficient to form the substantially dehydrated bioprosthetic valve; and

storing the substantially dehydrated bioprosthetic valve in a container that is essentially free of liquid.

4. The method of claim 3 further comprising the step of sterilizing the substantially dehydrated bioprosthetic valve by exposure to one of ethylene oxide gas or ionizing radiation either before or after placement in the container.

5. The method of claim 1, wherein said step of crimping the expandable support member further comprises the step of exposing the substantially dehydrated bioprosthetic valve to a re-hydrating fluid.

6. The method of claim 1, wherein blood re-hydrates the substantially dehydrated bioprosthetic valve before the expandable support member is placed at the desired location.

7. The method of claim 1, wherein blood re-hydrates the substantially dehydrated bioprosthetic valve after the expandable support member is placed at the desired location.

8. The method of claim 1, wherein said step of placing the expandable support member at a desired location within the cardiovascular system of the subject is done percutaneously via the delivery catheter.

9. The method of claim 1, wherein said step of placing the expandable support member at a desired location within the cardiovascular system of the subject is done via a minimally invasive, open surgical approach.

10. A method for implanting a valve having at least one valve leaflet within the cardiovascular system of a subject, said method comprising the steps of:

preparing a substantially dehydrated bioprosthetic valve;

providing an expandable support member having oppositely disposed first and second ends and a main body portion extending between the ends;

attaching the substantially dehydrated bioprosthetic valve to the expandable support member so that the substantially dehydrated bioprosthetic valve is operably secured within the main body portion of the expandable support member;

crimping the expandable support member into a compressed configuration;

exposing the substantially dehydrated bioprosthetic valve to a re-hydrating fluid; and

placing the expandable support member at a desired location within the cardiovascular system of the subject.

11. The method of claim 10, wherein said step of placing the expandable support member at a desired location within the cardiovascular system of the subject further comprises the steps of:

loading the expandable support member into a delivery catheter;

obtaining access to the desired location;

delivering the expandable support member to the desired location; and

expanding the expandable support member into engagement with the cardiovascular tissue at the desired location.

12. The method of claim 10, wherein said step of preparing a substantially dehydrated bioprosthetic valve further comprises the steps of:

obtaining a bioprosthetic valve;

treating the bioprosthetic valve with an aqueous treatment solution comprising a dimensional stabilizer for a time sufficient to form the substantially dehydrated bioprosthetic valve; and

storing the substantially dehydrated bioprosthetic valve in a container that is essentially free of liquid.

13. The method of claim 12 further comprising the step of sterilizing the substantially dehydrated bioprosthetic valve by exposure to one of ethylene oxide gas or ionizing radiation either before or after placement in the container.

14. The method of claim 10, wherein said step of crimping the expandable support member further comprises the step of exposing the substantially dehydrated bioprosthetic valve to a re-hydrating fluid.

15. The method of claim 10, wherein said step of placing the expandable support member at a desired location within the cardiovascular system of the subject is done percutaneously via the delivery catheter.

16. The method of claim 10, wherein said step of placing the expandable support member at a desired location within the cardiovascular system of the subject is done via a minimally invasive, open surgical approach.

17. A method for implanting a valve having at least one valve leaflet within the cardiovascular system of a subject, said method comprising the steps of:

preparing a substantially dehydrated bioprosthetic valve;

providing an expandable support member having oppositely disposed first and second ends and a main body portion extending between the ends;

attaching the substantially dehydrated bioprosthetic valve to the expandable support member so that the substantially dehydrated bioprosthetic valve is operably secured within the main body portion of the expandable support member;

exposing the substantially dehydrated bioprosthetic valve to a re-hydrating fluid;

crimping the expandable support member into a compressed configuration; and

placing the expandable support member at a desired location within the cardiovascular system of the subject.

18. The method of claim 17, wherein said step of placing the expandable support member at a desired location within the cardiovascular system of the subject further comprises the steps of:

loading the expandable support member into a delivery catheter;

obtaining access to the desired location;

delivering the expandable support member to the desired location; and

expanding the expandable support member into engagement with the cardiovascular tissue at the desired location.

19. The method of claim 17, wherein said step of preparing a substantially dehydrated bioprosthetic valve further comprises the steps of:

obtaining a bioprosthetic valve;

treating the bioprosthetic valve with an aqueous treatment solution comprising a dimensional stabilizer for a time sufficient to form the substantially dehydrated bioprosthetic valve; and

storing the substantially dehydrated bioprosthetic valve in a container that is essentially free of liquid.

20. The method of claim 19 further comprising the step of sterilizing the substantially dehydrated bioprosthetic valve by exposure to one of ethylene oxide gas or ionizing radiation either before or after placement in the container.

21. The method of claim 17, wherein said step of placing the expandable support member at a desired location within the cardiovascular system of the subject is done percutaneously via the delivery catheter.

22. The method of claim 17, wherein said step of placing the expandable support member at a desired location within the cardiovascular system of the subject is done via a minimally invasive, open surgical approach.